N Engl J Med 2011; 365:193-195 July 21, 2011
On April 25, 2011, the Food and Drug Administration (FDA) announced its intention of regulating “electronic cigarettes” as tobacco products, having failed in its initial attempt to regulate them as drug-delivery devices. Previously, products delivering refined nicotine had either been regulated as pharmaceuticals (and subjected to the “safe and effective” standard used in drug approvals) or swiftly removed from the market to protect public safety. The FDA's decision came after the courts blocked the agency from regulating these products as drug-delivery devices, holding that under the 2009 Family Smoking Prevention and Tobacco Control Act (FSPTCA), products containing nicotine derived from tobacco but making no therapeutic claims must be regulated as “tobacco products.”1 Together, this ruling and the FDA's announcement have upended the status quo. Unless and until the FDA asserts its authority under the FSPTCA, manufacturers can sell concentrated nicotine products directly to consumers, raising serious safety concerns.
Ultimately, Congress, the courts, and the FDA must find an effective regulatory approach for nicotine products that minimizes risk and maximizes the public welfare. Refined nicotine delivered by inhaler devices should be included in any such regulatory scheme, as should tobacco products promising “reduced or modified risk.” To address the latter, the FSPTCA offers a new public health standard, requiring manufacturers and the FDA to focus on the goal of reducing the number of people who die or are harmed by tobacco, taking into consideration the risks and benefits to the entire population. For refined nicotine to ever be safely marketed under these standards, regulation must also include strict requirements — no different from those for other consumer drug products — for evidence of safety, consistent specifications, quality control, and functional dose limitations.
Regardless of how regulation of refined nicotine occurs, it must ensure that no existing or future products slip through the cracks. Some e-cigarette proponents have argued that strict regulation or withdrawal of the devices from the market would harm current users, forcing them to return to smoking tobacco. In reality, both smokers and e-cigarette users have many alternatives: multiple nicotine products, approved, regulated, and deemed to be safe and effective by the FDA, are already widely available (in addition to other effective cessation tools, such as varenicline, bupropion, telephone quit-lines, and Web-based services). Pending more aggressive regulation, clinicians should advise patients wishing to use nicotine to stick to the FDA-regulated forms, such as patches, gum, lozenges, nasal spray — or even, perhaps, the existing FDA-approved inhaler.